Medical Component and Device Manufacturing

Helix Medical is a global custom manufacturer for the medical device and healthcare industries with seven manufacturing operations worldwide. Medical manufacturing capabilities include component design and development, silicone molding, thermoplastic molding, silicone extrusion, thermoplastic extrusion, catheter development and manufacturing, assembly, packaging, and engineering services. Helix Medical operates FDA-registered medical device facilities, certified ISO 13485 with Class 7 & 8 cleanrooms.

Established in 1984, Helix Medical currently manufactures in California, Massachusetts, Germany, Ireland, and China.  A facility in Costa Rica begins production in 2012.

Silicone Molding / Thermoplastic Molding

Molding capabilities include low- to high-volume injection molding, liquid injection molding (LIM), transfer/compression molding, micro-molding, insert molding, over-molding, and two-shot molding. Additional specialties include patented cold runner technology for silicone molding, advanced hot runner systems for both valve gate and open tip thermoplastics to reduce overall scrap, scientific injection molding, plus expertise in short- and long-term implantable LSR and HCR silicones.

Helix Medical offers a wide range of value-added services from sterilization, assembly, and packaging to annealing, thermoforming, and pad printing.

Silicone Extrusion / Thermoplastic Extrusion

Extrusion capabilities encompass a wide variety of tubing types, including single- and multi-lumen, braided reinforced, cord, color stripe, close tolerance, profiles and tapes, as well as co-extrusion, pigmenting, and radiopacity.

Our close tolerance extrusions, in both silicone and TPE’s, provide the precision and quality required for the most demanding applications. Value added services include cut-to-length, skiving, pad printing, bonding/gluing, punching, parylene coating, proprietary striping, and a wide selection of long-term implant, medical, and pharmaceutical grade silicones.

Complex Catheter Development and Assembly

The Helix Medical joint venture company VistaMed provides innovative catheter solutions—from concept design to product development and high-volume manufacturing—covering a full range of technologies. Custom catheter capabilities include extrusion, insert molding, braiding, tip forming, bonding, precision hole drilling, laser cutting, balloon forming, printing, packaging, labeling, and sterilization.

Design and Engineering

Helix Medical offers fully integrated design, engineering and tooling capabilities to take you from concept through production quickly, efficiently and economically. Working from your drawing or SolidWorks model, we use an advanced CAD/CAM system to help design, prototype and fabricate silicone and thermoplastic components and assemblies of the highest quality. Coming up with solutions to meet even the most challenging design problems is one of our greatest strengths. We offer custom, in-house design and construction of molds, tools, and other equipment using the latest CNC technology.

HelixMark® Silicone Tubing

Helix Medical also manufactures the HelixMark® brand of platinum-cured silicone tubing and fluid handling components for pharmaceutical, biotech and IVD. HelixMark products are available off-the-shelf in an extensive array of product types and sizes. Tubing products include PharmaFocus, peristaltic pump tubing, braided reinforced, standard, color stripe, close tolerance tubing, stoppers and gaskets, custom assemblies, and custom packaging. We offer a wide choice of silicones and material certification and lot traceability is included with every product.

View the HelixMark® Silicone Products Catalog.

Quality You Can Count On

We work closely with the companies we serve to implement customized validation and quality assurance systems. Our objectives are to ensure compliance with all FDA, ISO, and MDD requirements, and to fulfill each of our customer's specific requirements.

• FDA-registered facilities in California, Ireland, and Costa Rica
• ISO 13485 certification
• ISO 14644 Class 7 & 8 cleanrooms
• CDPH-licensed medical device manufacturer
• cGMP and QSR compliant globally
• Climate-controlled metrology laboratory
• First article inspections, process capability studies, Gauge R"R

A Lean Manufacturing Partner

We draw on extensive material, process, and tooling expertise combined with integrated project management to deliver validated processes. Using lean manufacturing tools such as Kaizen, Value Stream Mapping, 3P, Six Sigma, and scientific injection molding capability, we drive out waste, optimize value adding activity, and shrink lead times.